This Funding Opportunity Announcement (FOA) invites cooperative agreement applications for investigator-initiated clinical trials of natural products to treat clinical symptoms such as those associated with sleep disturbance, pain conditions, or some mental health conditions (e.g., mild to moderate depression, anxiety, and post-traumatic stress), or examine the effects of probiotics and other natural products on gut-microbiome interactions with the brain and/or immune system. All applications submitted under this FOA must be supported by sufficient preliminary data of bioavailability and documentation that the natural product produces a replicable and measurable biological signature (i.e., measure of the mechanism of action), whenever it is possible or practical to measure and used by the patient population of interest.
Applications submitted to this FOA should propose a phase II clinical trial determining the optimal dose of a given natural product for use in a future multi-site clinical trial; or determining which patient phenotypes will be responders versus non-responders to the natural product to inform inclusion/exclusion criteria of a future efficacy study. Clinical trials submitted under this FOA are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This FOA will not support multi-site efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer.
Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this FOA.
Companion FOAs:
PAR-17-319, R61/R33 Exploratory/Developmental Phased Award
PAR-17-318, R33 Exploratory/Developmental Grants Phase II
PAR-17-174, UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement
Deadlines:
PAR-18-125 Expiration Date November 5, 2019
